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GlaxoSmithKline anti-HIV injectable drug gets the latest FDA approval!
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GlaxoSmithKline’s anti-HIV injectable drug gets the latest FDA approval! Direct injection and prolonged efficacy.
More than a year after GlaxoSmithKline’s (GSK) AIDS- fighting drug Cabenuva was approved , GSK’s HIV unit ViiV Healthcare has found another way to make Cabenuva more attractive.
Cabenuva is made up of two extended-release injections: cabotegravir, developed by ViiV, and rilpivirine, made by Johnson & Johnson’s Janssen, which is also sold separately under the Edurant and Rekambys brand names. Previously, patients on long-acting HIV therapy were given oral cabotegravir and rilpivirine for a month to assess drug tolerability, followed by injection therapy.
But on March 24, the FDA approved an update that allows patients to choose their own time period for the oral medication, and also allows patients to start long-acting injections directly.
“Since launching Cabenuva, we have focused on optimizing the experience for people living with HIV and healthcare professionals,” Lynn Baxter, head of North America at ViiV, said in a release.
ViiV stated that the FDA’s decision was based on the results of the Phase III FLAIR clinical trial, which showed that in patients who started injections after taking oral drugs, or direct injections without oral drugs, virological suppression, safety, and tolerability were maintained. and pharmacokinetic results are very similar.
Cabenuva caused quite a stir last January. It is the first FDA-approved injectable HIV drug on the market, replacing daily oral medication with a monthly injection.
Just last month, ViiV celebrated the drug’s one-year anniversary by launching a new indication that allows some patients to receive only six treatments a year, every two months.
The difference between the one-month and two-month drugs is the larger dose . ViiV previously revealed to Endpoints News that the company is looking for new technologies to extend Cabenuva’s duration of efficacy to three months, six months or even longer.
Last year, the drug grossed more than $50 million (£38 million).
Still, rivals are keeping ViiV on their toes, with Gilead Sciences’ long-acting drug lenacapavir not far behind. Earlier this month, the FDA issued a CRL (Revocation of Credentials List) to it due to CMC (Chemical Component Manufacturing and Control) issues with compatibility between the drug and its container bottle .
However, this treatment modality has the potential to provide multidrug-resistant HIV patients with injections every six months .
Last month, Kim Smith, the company’s head of research and development, told Endpoints: “We have developed the first long-acting therapy, and while our competitors have been chasing us, we are at least five years ahead of them. We hope to take this therapy to the next level based on the experience gained in developing Cabenuva. “
GlaxoSmithKline’s anti-HIV injectable drug gets the latest FDA approval!
(source:internet, reference only)